Manager/Associate Director Global Regulatory Affairs - Belgium
Want to know company name or location? Company managed [?]
- We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
- Employees of our Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
- Our company is one of the most innovative pharmaceutical companies in the world.
- Our research and development center develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
The Global Regulatory Scientist provides support to
- the Global Regulatory Leaders (GRL) for regulatory activities for early and full development products in the assigned portfolio, including assuring that content and intent of regulatory filings and documents support the global regulatory strategy.
- the ID&GPH GRA group as point of contact for well-defined cross group activities.
Key responsibilities include the following:
- Lead preparation, review and approval of regulatory actions and documents as assigned.
- Lead the preparation, consolidation and maintenance of a global strategy plan as assigned.
- Participate in global regulatory team meetings as appropriate.
- Advice the regulatory team on applicable regulatory requirements and project specific regulatory issues.
- Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area as needed.
- Assist in maintenance of specific regulatory and tracking systems. Liaison with stakeholders within and outside GRA Companies.
- Assist in ensuring 100% compliance with agreements as signed with external partners.
- Coordinate tracking and documenting of regulatory activities as assigned.
- Assist in the preparation of meetings and responses to queries as assigned. Input in process development
- Assist in development and improvement of processes related to regulatory activities. Clinical Trials & pre-approval access programs
- Review clinical trial plans and protocols and ensure alignment with regulatory requirements.
- Provide regulatory support (strategy and tactics) for global submission special access programs as assigned. Health Authority Submissions (e.g. Briefing Books, Scientific advice packages, Marketing Authorization Applications (MAAs), New Drug Applications (NDAs) or equivalent regional or national documents, life-cycle submissions and other)
- Provide support in putting a global submission plan together in working with GRT members.
- Provide regulatory support throughout registration process and life-cycle management as assigned.
- Assist with timely availability of submission documents and ensure that all document components are in place on time.
- Draft and review some document content as needed.
- Understand submission details and liaise with Submission Management.
- Review and approve submission plans as needed.
- Review of some submission documents to ensure compliance with regulatory requirements.
- Assist with submission and acceptance of the submission package. General
- Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
- Serve as the Regulatory representative on specific multi-discipline teams.
- Keep abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidance and requirements related to those areas.
- Minimum of Bachelor degree in a scientific discipline or equivalent by experience
- Minimum of 5 years pharmaceutical, vaccines and/or medical devices industry or health authority experience.
- Experience in Regulatory Affairs as well as working knowledge of regulatory requirements
- Understanding of the drug development process and regulatory submission and approval process
- Knowledge of the regulatory environment, guidelines and practices.
- Able to critically review and compile regulatory documents
- Understanding of submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSUR’s, renewal applications
- Knowledge of Microsoft programs as well as electronic management systems (e.g. ERIS, GRAIL)
- Understanding competitive landscape, e.g., views of HA, regulatory precedence, labelling differences and therapeutic area issues
- Basic medical/scientific understanding in a clinical area
- Able to work successfully within a team environment and as an individual contributor;
- Project management skills;
- Ability to manage multiple tasks, projects, priorities and complex situations systems simultaneously
- Strong interpersonal and communication skills: fluent in English
- As an employee we consider you as our most valuable asset.
- We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
- Through e-university, on the job training, various projects and programs, we ensure your personal growth.
- Our benefits make sure we care for you and your family now and in the future.